Adult Stem Cell Success Stories 2008 Update: January-June

by William L. Saunders, Jr., David Prentice, Simona Beskova, and Martin Kolesar[1]

We are pleased to present FRC's June update on advances in human treatments and research with adult stem cells. This is the third report. The prior ones were "Adult Stem Cell Success Stories - 2006"[2] and "Adult Stem Cell Success Stories-2007 Update".[3] Every six months, we will present new cases of people being helped by adult stem cells, which are abundant throughout the human body and whose use does not pose the ethical dilemmas encountered with embryonic stem cell research. Adult stem cells are already being used to treat over 73 different conditions and are the subject of over 1400 FDA approved trials. We invite you to read about real people being helped by adult stem cell research.

Autoimmune Disorders

Jill Rosen was diagnosed with antiphospholipid syndrome, a form of lupus and an autoimmune disorder causing blood clots, in 1997. Her health was gradually deteriorating. Between 2002 and 2004 she was in hospital every two months, was not responding to treatments and was exhausted. She contacted Dr. Richard Burt from Northwestern University Feinberg School of Medicine, who was working on a new treatment involving stem cell transplants for auto immune disorders.

In February 2005 she began chemotherapy, and a month later her own stem cells were replanted into her body. She was released from the hospital after 3 weeks. For several months she did not experience any notable improvement. However, in 2006, her conditions improved dramatically. Follow ups from 2006 through 2008 confirmed drastic improvements. Jill says that her family and friends all celebrate her new birthday on March 7, 2005 , the day her own adult stem cells were transplanted back into her body.[4]

Amy Daniels is another successfully treated patient of Dr. Burt. In October 2004 she was diagnosed with scleroderma, an autoimmune disease that affects connective tissue in the body, the tissue that supports skin, and internal organs. The disease causes organs to grow hard and thick.

Amy's case of scleroderma caused her skin to become very tight. She could not bend her head backwards; she could not make a fist or cross her fingers; her teeth were getting loose and she had trouble closing her mouth. Finally the illness attacked her lungs, decreasing their capacity from over 90 percent to 43 percent.

She contacted Dr. Burt and was accepted for treatment. Amy was given chemotherapy and immunosuppressants to eliminate her malfunctioning immune system. In April 2007 her own stem cells were reinfused to her body to rebuild her immune system. After 6 months she returned to work, her skin returned to normal, and her lung capacity increased to 57 percent. Amy confirms the dramatic improvements: "I can lift my arms over my head and drop my head back without any discomfort.... I can open my mouth wide enough to yell at my children.... I can go up a flight of stairs. I can chase my kids around the park."[5]

Barry Goudy is also Dr. Burt's patient. All three patients presented their stories at an event hosted in the U.S. Capitol Building in March 2008 in the presence of Dr. Burt.

Barry Goudy was diagnosed with multiple sclerosis in May 1995. Over the years the treatment became less effective.

In 2003, Barry was accepted into Dr. Burt's study and received his adult stem cell transplant in July. After 4 months he was able to get back to work symptom free. In 2008, he will celebrate five years of being free of multiple sclerosis symptoms. "I look forward to continuing to live an active, productive MS-free lifestyle that includes my work as well as playing racquetball, golf and coaching hockey," affirms Barry.[6]

In February 2008, Dr. Burt authored a review of previously published reports of clinical applications using adult stem cells in JAMA (Journal of the American Medical Association), a highly cited weekly medical journal. After examination of more than 300 reports involving thousands of patients, Dr. Burt and his team validated that "[s]tem cells harvested from blood or marrow... under appropriate conditions in select patients, provide disease-ameliorating effects in some autoimmune diseases and cardiovascular disorders."[7]

In patients with multiple sclerosis, immunosuppressive therapy followed by autologous hematopoietic stem cell transplantation elicited high response rates and improved quality of life for up to 6 years. The results of the study were presented at the 18th Meeting of the European Neurological Society in Nice , France. Tatiana Ionova, MD, PhD, of the Department of Hematology, Pirogov National Medical Surgical Center in Moscow , Russia reported that during the last decade 56 patients with all types of multiple sclerosis (primary progressive, secondary progressive, progressive relapsing, relapsing remitting) were studied. Out of the 26 patients included in the quality-of-life analysis, 24 exhibited a response and preserved a good quality of life during the follow-up. No unexpected treatment-related adverse events were observed. According to Dr. Ionova, immunosuppressive therapy plus autologous hematopoietic stem cell transplantation appears to be a safe and effective therapy for multiple sclerosis.[8]

Genetic Disease

Physicians at the University of Minnesota and the University of Minnesota Children 's Hospital, Fairview believe they are on the path to a cure for Nate Liao, a 25-month-old from Clarksburg , New Jersey. Nate has a fatal genetic skin disease, recessive dystrophic epidermolysis bullosa (RDEB). In October 2007 he underwent experimental therapy, using a cord blood and bone marrow transplant. Dr. John Wagner, the lead University of Minnesota Medical School physician who developed the clinical trial, said that Nate's quality of life is forever changed. Because they lack collagen type VII , children with RDEB have skin that is exquisitely delicate. The skin and lining of their gastrointestinal tract is fragile; tearing and blistering occur with minimal friction. Those affected must have their entire body continuously wrapped in bandages. Those who do not succumb from malnutrition and infection in childhood will acquire a uniformly fatal, aggressive cancer of the skin in young adulthood. Nate Liao received marrow- and umbilical cord blood-derived stem cells and progenitor cells from his healthy, tissue-matched brother. Over the next six months, the skin and lining of his gastrointestinal tract slowly improved, and skin biopsies on days 60, 130, and 200 documented increasing amounts of collagen type VII. By day 130, Nate's skin and the lining of his gastrointestinal tract were beginning to show clinical signs that his skin was anchoring to his body. Based on the success seen with treating Nate, Wagner will enroll additional RDEB patients into the clinical trial.[9]

Heart Tissue Regeneration

Carron Morrow suffered her fourth heart attack at the age of 58 in July 2006. The decreased performance of the heart changed her life dramatically. Instead of her typical 70 hour workweek, she could only walk for 20 feet before taking rest.

Carron enrolled in a FDA-approved study at the Texas Heart Institute Stem Cell Center. In October 2006, bone marrow was removed from her hip and cultivated. The cultivated stem cells were transplanted into the right side of her heart, which was heavily damaged. By the spring of 2007, her life was back to normal. Working up to 80 hours is not a problem for her, and her doctor confirmed that the damaged part of her heart is now normal.[10]

Benjamin Calvo, a math teacher, is one of many heart attack patients taking part in an adult stem cell clinical trial. Calvo suffered a heart attack on his way home from a weekend vacation. In the hospital he was given a series of EKGs and a dose of nitroglycerin. He was then taken to the Heart Hospital of Austin, Texas, where he underwent two angioplasties and received 6 stents. Afterward, he agreed to participate in an adult stem cell research study for heart attack patients using adult stem cells. The stem cells were from the donated bone marrow of healthy adults. He was injected intravenously with adult stem cells intermittently over a two-year period. "We hang a bag that has millions of stem cells in it," Dr. Roger Gammon, director of research at Austin Heart, said. "They infuse through the vein and travel to where there is an injury. It's just a simple intravenous infusion over 30 minutes." According to Gammon, heart attack patients that received adult stem cells intravenously not only showed no negative side effects, but displayed an impressive number of beneficial results. Because it is thought potentially to cause arrhythmia, patients that received the treatment were monitored for it and actually showed an improvement in heart function. [11]

Coenie de Jongh , a 68-year-old man from Bloubergstrand near Cape Town , South Africa underwent 21 years of unsuccessful heart treatments, including several heart procedures. Coenie had his first heart attack at the age of 40. A bypass operation followed and his condition improved, but seven years later Coenie's health started deteriorating again. More operations, more intense treatment and another bypass operation followed, but his health took a turn for the worse. At that time, Dr Andre Saaiman from Kuils River Hospital was conducting research involving the use of stem cells. He was inspired by the work done by Prof Philippe Menasche from France, who had found a way to inject stem cells derived from skeletal muscle into failing hearts. After getting ethical approval from Stellenbosch University , Dr Saaiman decided to try out the novel therapy on Coenie, who by then was extremely ill and confined to a wheelchair. In December 2004 adult stem cells were taken from Coenie's upper leg, which Saaiman cultivated in a laboratory. A month later, he injected the cultivated stem cells into 40 areas of Coenie's failing heart. In less than two weeks, Coenie's condition improved dramatically. "He was a different person," Marlene, Coenie's wife, recalls. "Before the operation, he had only 10 percent heart function; afterwards, his heart function shot up to almost 35 percent. It was amazing to see what he could do again. He started walking again, and could lead a relatively normal life."[12]

Adult stem cells were used to repair the heart of Steve Nemeth. A large artery in his heart became clogged and the only conventional option was a bypass. But Steve decided to participate in a small Phase 1 trial at the National Center for Regenerative Medicine.[13] Doctors suggested using a stem cell re-infusion to attempt to increase the capacity of smaller blood vessels around the clogged artery. In the procedure, stem cells were harvested from the bone marrow in Steve's hip. Magnetic sorting mechanism identified the stem cells with the potential to form new blood vessels and they were then infused back into the patient's heart using a catheter.

There is a new and more effective system which enables doctors to inject the stem cells to the exact area which needs to have blood circulation improved. Out of the eight patients who participated in the trial, seven, including Steve, got better. The improvement was measured by stress tests before and after the treatment and by changes in heart size. [14]

Several studies involving hundreds of patients with advanced heart failure showed considerable improvement of patients' conditions. In a study by Dr. Warren Sherman of Columbia University , 83 percent out of 300 treated patients improved. They underwent a treatment with stem cells harvested from their own thigh tissue. A separate study by Dr. Dib of the University of California ended up with similar results. [15]

Houston researchers have launched an experimental trial in which primitive adult stem cells are injected directly into the hearts of heart attack victims, an attempt to prevent heart failure from developing. In April 2008, Texas Heart Institute(THI) announced they had discharged the first patient in the new trial-a 65-year-old man, who was injected with stem cells 10 days after suffering a massive heart attack. The new study differs from THI's previous work because it involves stem cells taken from the bone marrow of a donor. Known as mesenchymal precursor stem cells, the cells are considered to have greater plasticity than other adult stem cells. Harvested from the donor's bone marrow, cells are injected directly into the heart. They do not pose any issues of rejection by the patient's immune system, researchers say. THI is expected to announce results of the U.S. study using a patient's own stem cells to treat their advanced heart failure soon. A similar study of patients in Brazil found those given stem cells had better blood flow and oxygen utilization than those who did not get the cells. "Questions about what is the best cell, the best way to deliver the cells and how the cells work can only be answered by doing a number of studies like this," said Dr. Joshua Hare, director of the Interdisciplinary Stem Cell Institute at the University of Miami School of Medicine.[16]

Bioheart, Inc. announced April 1, 2008 that final follow-up patient data was presented at the American College of Cardiology, suggesting that MyoCell(R) myoblast clinical cell therapy[17] is a safe and potentially effective alternative treatment to standard medical therapy for improving heart function among patients with previously implanted cardiac devices who are experiencing congestive heart failure.[18]

Breast Reconstruction

In December 2007, it was reported that adult stem cells have been for the first time used to repair breast deformation in women who have had cancerous tumors removed. The stem cells were harvested from liposuctioned fat. The procedure, a form of cosmetic surgery, has been tested on 21 women in Japan. About 80 percent of the women were satisfied with the results of the treatment. [19]

Doctors in the U.S. are already working on similar studies. The procedure would likely provide a breakthrough treatment for millions of women who underwent tumor removal and were left with deformed breasts.[20]

Graft vs. Host Disease

Dr. Stanton Gerson, director of the Ireland Cancer Center at University Hospital 's Case Medical Center , is using marrow-derived stem cells to lessen a patient's immune reaction to transplants from another donor. Known as "graft vs. host disease," the reaction occurs when bone marrow is transplanted to a patient's body to treat leukemia but instead attacks the patient. About 30 to 60 percent of children treated develop the condition. Some cases do not respond to treatments by immunosuppressive drugs and the patient dies within three months from liver failure, diarrhea, and bleeding in the gut.

Gerson hopes that a second transplant using different marrow cells, called mesenchymal cells, can suppress that immune response. This possibility was discovered by accident when Gerson injected patients with stem cells at the time of the bone-marrow transplant in hopes of speeding the growth of new blood cells. That did not happen, but he soon figured out that those who were injected at the time of the transplant ''lived better and they lived longer.'' Sixty-five-year-old Robert Wise of Geneva was one of those patients. In 1999, he underwent a bone-marrow transplant from his brother, along with the injection of additional stem cells. ''I've been perfect ever since then and that was in 2000.''[21]

Osiris Therapeutics of Maryland cooperated with Vinod Prasad at Duke University Medical Center in North Carolina to perform a study involving children who developed graft vs. host disease and did not respond to conventional treatment. In the study, twelve children aged four months to 15 years received injections of mesenchymal stem cells. Seven have been completely cured from graft vs. host disease and the situation of the other five improved.[22]

Osiris Therapeutics also announced in May 2008 it has been given clearance by the U.S. Food and Drug Administration (FDA) to initiate an expanded access treatment program for Prochymal, making the investigational stem cell product available to children with life-threatening graft vs. host disease. Prochymal, a formulation of adult mesenchymal stem cell administered through a standard intravenous line, is currently in phase III clinical trials, the final stage of clinical testing before submission to FDA for marketing approval. "Prochymal has had a profound positive impact on the children that we have treated, all of whom had exhausted available therapeutic options," said Paul Szabolcs, M.D., Pediatric Blood and Marrow Transplant Program at Duke University. "Since there are no approved treatments for Graft vs. Host Disease and mortality is so high, gaining faster and more reliable access to Prochymal will be very helpful."[23]

Leukemia

Sorrel Mason from England was diagnosed with a rare form of acute myeloid leukemia at the age of two. The doctors predicted she had a 30 percent chance of survival. The treatment of acute myeloid leukemia is based on an adult stem cell transplant, so a worldwide search for a matching stem cell sample was started. Finally, a set of cells was found in Tokyo, and the treatment at Bristol Royal Hospital for Children in 2007 was successful. Samantha Mason, Sorrel's mother, praised the doctors at the hospital's bone marrow transplant unit: "Sorrel would be dead now if she had been left untreated. They were the most terrifying months our family could live with, but the doctors pulled off a miracle."[24]

Olga Reagor was diagnosed with chronic myelogenous leukemia and underwent drug therapy in conjunction with chemotherapy before learning about an adult stem cell transplant. Her brother was a perfect match, so she received adult stem cell treatment from his cord blood. After eight years of being cancer-free she now considers herself healed. "The doctors do not like to use the word 'cured,'" she said, "but I use it because I take no medication and am back working at 110 percent."[25]

Organ Replacement

Scientists in Finland replaced a 65 year old patient's upper jaw in a revolutionary procedure after his jaw had been previously removed because of a tumor. Riitta Suuronen of the Regea Institute of Regenerative Medicine at University of Tampere said: "There have been a couple of similar-sounding procedures before, but these didn't use the patient's own stem cells that were first cultured and expanded in laboratory and differentiated into bone tissue."[26]

Mesenchymal stem cells harvested from patient's body fat were attached to a scaffold and put inside patient's abdomen. Mesenchymal stem cells have the ability to turn to bone, muscle and blood vessels. After nine months of growing, the block was transplanted into the patient's head. "From the outside nobody would be able to tell he has been through such a procedure," professor Suuronen said. The team followed the EU guidelines and no materials from animals were used to avoid any risk of transmitting animal viruses.[27]

Neuroblastoma

In December 2007, umbilical cord stem cells were used to treat 2 year old Caden Ledbetter, after he developed neuroblastoma, a fast growing cancer of the nervous system, which spread to his bones, liver and bone marrow. In the procedure, cancerous cells in Caden's body were eliminated with chemotherapy. Afterwards, stem cells from his own umbilical cord, that was saved when Caden was born, were injected into his body. The cells grew and rebuilt his immune system.[28]

Organ Transplants

Adult stem cells are also used in innovative therapies that enable patients to stop taking immunosuppressive drugs and eliminate chances of organs being rejected. The procedure involves transplanting donor stem cells into the recipient's body. This "tricks" the immune system, which is then more likely to accept the donor organ as its own.

Three studies presented improvements in patients with kidney transplants after the therapy. The most successful was Dr. David Sachs' study at Massachusetts General Hospital in Boston, in which four out of five patients were able to stop taking immunosuppressives and their kidney function has remained stable.[29]

Parkinson's Disease

A study by Instituto Brazzini Radiologos Asociados in Lima , Peru , showed considerable improvement in Parkinson's symptoms after stem cell implants. Doctors registered various degrees of beneficial changes in brains of all 47 patients within one week of the treatment. A team of Dr. Augusto Brazzini Armestar, the director of the institute, infused autologous stem cells derived from bone marrow into the arteries that supply blood to parts of brain that are typically damaged by Parkinson's disease.[30] Dr. Armestar explains: "Stem cells from bone marrow have the ability to differentiate into neurons and other tissues." About three quarters of the patients achieved more than 50 percent improvement at the one month follow-up.[31] Dr. Armestar concludes that "[the] findings show a clinical recovery of extrapyramidal symptoms, which are maintained over time, as well as function recovery, representing a better metabolism of neurons and better performance in the brain."[32]

Cerebral Palsy

Dallas Hextel was diagnosed with cerebral palsy, a brain damage that influences muscle control, soon after he was born. "He would cry for three hours straight like he was in pain. He couldn't really focus on things. When he started eating baby food he had chew-trouble, controlling his tongue," explained his mother Cynthia. Fortunately for Dallas, his parents had his umbilical cord blood stored when he was born. He was accepted to a clinical trial at Duke University. In a procedure that took less than an hour, stem cells harvested from his umbilical cord blood were infused intravenously. After just five days, Dallas , who had been speechless before, said "mama" for the first time. He was able to wave, laugh and looked more curious.[33]

Dallas is a part of a study conducted at Duke University. Out of 12 children who underwent the procedure, the conditions improved dramatically for him and one other child. Other patients have made more modest improvements. Dr. Joanne Kurtzberg, director of the Pediatric Blood and Marrow Transplant Program at Duke University Medical Center , cautions that at this stage of the study the improvements cannot be attributed to the treatment with certainty but says the treatment definitely appeared to have benefited Dallas.[34]

Bone Healing

Monique Biggins suffered a double fracture of her collarbone while playing softball. In her words, "I was running after a line drive and my foot got... stuck in the turf and my body weight was propelled forward and the shoulder took all that impact." Doctors performed multiple surgeries on her over two years and inserted a plate with five screws to help her collarbone to unify. It did not bring any success.[35]

Finally, she approached Dr. George Muschler from the Cleveland Clinic in Ohio. He was performing experimental treatments of bones using adult stem cells. Monique's own stem cells were injected into the fractures and the collarbone successfully unified. "It was a miracle. Because you could see it in the X-ray, there's just like a gap, there's no bone, and then later on it's a solid bone," she described the result. Dr. Muschler said that the procedure had a lot of potential: "I think [the procedure] has applications to some challenges that might have previously cost patients their leg, because we didn't have a way to heal their bone."[36]

In a treatment using the same procedure Dr. Thomas Einhorn, chairman of orthopedic surgery at the Boston University School of Medicine and Boston Medical Center , succeeded in healing a patient's fractured hip using adult stem cells after seven conventional surgeries had not been successful. The procedure involved extracting stem cells from patient's bone marrow found in the pelvis. "By mixing the bone marrow cells with protein, it gives me a kind of a grouting material that I can use to fill in the gaps," Dr. Einhorn explains.[37]

Michael Arciero , 54, from Chessington in Surrey , England , had been diagnosed with tennis elbow in his right arm. "Whenever I tried lifting anything, pain shot all the way down to my hand," he recalls. Tennis elbow, which is known in medical terms as lateral epicondylitis, is a degenerative condition, which is caused by fraying of the tendon that joins the forearm muscle to the upper arm. A team working at the Royal National Orthopaedic Hospital in Stanmore, Middlesex, led by Dr David Connell, tested a new technique in a pilot study last year. In the new treatment, a piece of skin was taken from Arciero's hip and used to isolate stem cells. The cells were then injected under ultrasound guidance into the tendon defects. "After the procedure, I was told to avoid lifting anything heavy for a fortnight, but within two days the pain had gone. A week later, I was back at the gym," recalled Arciero. British researchers have already safety-tested the radical therapy in a pilot study of 12 patients. Eleven were cured within weeks with no side effects and only one patient failed to respond. Commenting on the research, Mr. Simon Owen-Johnstone, a consultant orthopaedic surgeon at St Bartholomew's Hospital in London, said: "This appears to be a radical solution for tennis elbow, and I would welcome any new treatment that helps these patients." The pioneering technique could also help treat tendon and ligament damage throughout the body, such as a torn Achilles tendon.[38]

When Dr. Scott Spann's daughter, who is the captain of the University of Texas swim team, suffered a serious shoulder injury, Dr. Spann, of Westlake Orthopedics Spine and Sports, said that the two of them decided to use adult stem cell therapy. She is now preparing to compete at the U.S. Olympic trials.[39] In April 2008, the U.S. government awarded an $85 million grant to establish the Armed Forces Institute of Regenerative Medicine. The institute will offer treatments using the procedure described above to soldiers injured in Iraq and Afghanistan , to provide hope to wounded veterans who would be otherwise unable to return to work or even walk.[40]

Mesoblast , a biotechnology company based in Melbourne , Australia , conducted a clinical trial of mesenchymal stem cell transplants. Ten patients with non-healing, long bone fractures of legs received various doses of stem cells and had been followed up for at least six months after the implantation.[41]

In seven of the ten patients, the long bone fractures unified and they were able to lead a normal life with healed legs. The remaining three patients show continuous new b
one formation. Prior to the therapy, none of the patients had shown any evidence of bone formation for at least 5 and up to 41 months. The study showed that the higher the dose of infused stem cells, the less time is needed for a bone to heal.[42]

Multiple Myeloma

In the spring of 2003, New York Mets pitching coach Don Baylor was diagnosed with multiple myeloma, a cancer of the plasma cells, which produce antibodies to help fight infection and disease. During the off-season, he underwent chemotherapy treatment in New York and had subsequent autologous stem cell transplantation at the City of Hope in Duarte, California.[43] In a similar fashion, New York Yankees pitching coach Mel Stottlemyre was treated for the same disease in 2000. Both of them have remained symptom free since they had been treated and have continued to pursue their baseball careers.[44]

Peripheral Vascular Disease (Arteriosclerosis of the Extremities)

Tom Van Lieshout suffered from peripheral vascular disease since 1985.[45] He has undergone six bypass operations on his leg since then, but his condition worsened in 2005. Walking even for a short distance caused him severe pain, and he was facing the possibility of a leg amputation.

Fortunately, he learned that researchers at Northwestern Memorial Hospital were conducting an experimental procedure using autologous stem cell transplants. After being accepted in 2006, adult stem cells associated with arterial growth were extracted from his bone marrow and injected in his calf and thigh. His leg started to improve rapidly. Blood flow in his leg was growing stronger and after six months he was able to walk for 15 minutes at a 16-degree elevation. "I cannot praise this enough.... And when I talk about this, it almost takes my breath away because that's the feeling I have for it. It's awesome," concludes Tom.[46]

Lower Limb Ischemia

Study participants in a Federal Drug Administration (FDA) protocol at TCA Cellular Therapy[47] that is using stem cells to treat lower limb ischemia are experiencing increased mobility and decreased pain in their lower legs. Lower limb ischemia is a condition where plaque build-up causes decreased circulation in the lower leg. Symptoms of the condition include intense pain and swelling. Study participants may have had different factors that contributed to their condition; common among them, however, was that more traditional treatments (involving stents and grafts) were ineffectual. Meryl Sharp was an avid gardener before she had to give up the hobby because she could no longer walk the length of the lawn without stopping to rest her throbbing legs. The study participants were referred by their vascular surgeons to TCA Cellular Therapy, where Gabriel Lasala, M.D. and Jose Minguell, Ph.D. have been authorized by the FDA to study the safety and efficacy of stem cell therapy for lower limb ischemia. "The similarity in the recovery of our patients is promising," said Dr. Lasala. "We find that the stem cells, once re-injected, go about forming new blood vessels, thus increasing circulation dramatically." Drs. Lasala and Minguell have developed a treatment where a patient's own stem cells are taken from the hip, grown in a sterile environment and then re-infused into 38 areas of the leg. So far, ten patients have received the stem cell treatment for peripheral vascular disease. "Patients are experiencing increased mobility within weeks of their infusions. The continued improvement throughout their recoveries is a positive sign," Lasala said. Sharp has gone back to gardening, creating a new antique garden with her husband in their front yard.

Carleton Wert could only walk 2 1/2 minutes on the treadmill before he underwent the stem cell therapy. At his three week check-up, he clocked 4 minutes. Within two months, his time improved to over 10 minutes. Wert, who was on disability because of the ischemia, is now seeking employment. Similarly, Michael Pearl could not even undergo the treadmill test prior to his infusion in mid-November because his pain was so intense. He went from walking 5 minutes at his one-month check-up to 18 minutes at the three-month mark. Perhaps most striking is the transformation experienced by Penny Kibideaux. Running out of options to treat her ischemia, Kibideaux had already scheduled a leg amputation. Under the advice of her physician, Kibideaux went to see Dr. Lasala. Just weeks after her November infusion, she walked several shopping malls as part of her Christmas shopping. She has also recently taken up line dancing.[48]

Vision Restoration

A man's vision has been restored by a corneal patch grown from adult stem cells by a team at the University of Melbourne 's Centre for Eye Research Australia (CERA) and the Bernard O'Brien Institute of Microsurgery (BOBIM). The research team was led by Dr Mark Daniell (CERA) and Dr Erik Thompson (BOBIM). The patch, which replicates the cornea, was cultivated from a single stem cell from a donor eye and was transplanted to the surface of the man's eyes. The process, known as a limbal stem cell transplant, is thought to be the first of its kind in Australia. The Melbourne success significantly advances international research in limbal stem cell transplantation in the eyes. The patient had severe vision loss caused by stem cell failure on the surface of the eye, causing scarring and a vascularised and opaque appearance. "He had reduced mobility, could not read and could not work, but he has now resumed duties as an accountant, enjoys sight, and has increased mobility and quality of life and renewed optimism," Dr Daniell reports. He says the surface of the man's eyes was removed and the patch (about 50mm long and a micron thick) was applied and is healing well. "This technique can now assist people with alkaline burns who have damage to the surface of their eyes."[49]

Sickle Cell Disease

Pamela Newton suffered from sickle-cell disease since she was a baby. Fifteen months ago, the pain from Newton's sickle cell disease was excruciating. She spent more time in the hospital than in her apartment, and was on 15 pain pills a day, all heavy narcotics. She was bleeding regularly and needed daily transfusions of platelets. Today, doctors at Johns Hopkins Hospital say that Newton is one of the first adults in the world to be cured of sickle cell disease-and the first using an experimental bone marrow transplant. It was two months after the transplant in December 2006 before Newton started to feel better. Slowly, the pain dissipated. Newton is planning for the future for the first time. Feeling a call to the ministry, she plans to enroll in Bible college in June 2008. What makes the Hopkins procedure different is that it allows patients to receive bone marrow from a donor who is not an exact match-a longtime obstacle to healing large numbers of people.[50]

Darlene Davis, whose son, Joseph Jr., was born with sickle cell anemia, said that the family waited for over a year but could not find a suitable donor. Their doctor then mentioned the option of using cord blood. After testing, Joseph Jr.'s brother was found to be a perfect match and his cord blood was used to treat Joseph Jr. According to his mother, Joseph Jr. was out of the hospital and completely healed within one month.[51]

William L. Saunders is Senior Fellow and Director of the Center for Human Life and Bioethics at Family Research Council

Dr. David Prentice is Senior Fellow for Life Sciences at Family Research Council, and a Founding Member of Do No Harm.

[1] Simona Beskova and Matrin Kolesar, natives of Slovakia , were Witherspoon Fellows at FRC in the Summer and Spring of 2008, respectively.

[17] MyoCell clinical cell therapy, developed by Bioheart, Inc., is currently being studied as an investigational product in Europe and the U.S. MyoCell clinical cell therapy is intended to be used to improve cardiac function after a patient has suffered severe heart damage due to a heart attack. The procedure involves a physician removing a small amount of muscle obtained from the patient's thigh. From this muscle specimen, autologous myoblasts (muscle stem cells) are then isolated, grown using Bioheart's proprietary cell-culturing process, and injected directly into the scar tissue of the patient's heart. The myoblast-based muscle formation in the newly populated regions of scar tissue are intended to improve cardiac function by helping the heart muscle beat more efficiently.

[45] According to MedlinePlus, a service run by The National Library of Medicine, "peripheral vascular disease is a disease of the blood vessels characterized by narrowing and hardening of the arteries that supply the legs and feet. This causes a decrease in blood flow that can injure nerves and other tissues." See The National Institutes of Health, "Arteriosclerosis of the extremities," MedlinePlus. Accessed at: http://www.nlm.nih.gov/medlineplus/ency/article/000170.htm ( 23 April 2008 ).

[47] TCA Cellular Therapy is the only private company in the United States that is participating in FDA protocols related to stem cell research. Under the direction of Medical Director Gabriel Lasala, M.D. and Scientific Director Jose Minguell, Ph.D., TCA Cellular Therapy is undergoing pioneering research with stem cell therapy for limb ischemia. Its affiliated company, LifeSource Cryobank, LLC is a privately-owned, FDA registered, state of the art laboratory committed to ensuring the safety and integrity of stem cells derived from both umbilical cord blood and adult bone marrow in a totally secure environment. Both companies are located in Covington , Louisiana.